SARS-CoV-2 in Stools Compared to Respiratory Viral Strains.

NCT05567419 | Unknown

• 1 other identifier: 2022-A00731-42
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to characterize and to quantify SARS-CoV-2 strains in stools, in comparison with the viral strains in respiratory samples, from patients hospitalized for COVID-19. The methods will be standard ddPCR quantifying SARS-CoV-2 RNA and next generation sequencing-whole genome sequencing. The expected results will allow us to better understand SARS-CoV-2 dynamics and compartmentalization, both in the respiratory tract and in digestive-related tissues, according to the evolution of SARS-CoV-2 variants.

Conditions

SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• SARS-CoV-2 dynamics in stools.

  Evolutive SARS-CoV-2 dynamics in stools compared to respiratory tract: molecular quantification (ddPCR) of SARS-CoV-2 variants genome in stools, compared to the viral quantification in respiratory samples.

  30 monthes

Secondary Outcomes (2)

• SARS-CoV-2 in stools compared to the virus in wastewaters.

  30 monthes

• Modelization of SARS-CoV-2 load in stools and COVID-19 global frequency.

  30 monthes

Interventions

Biological assays DIAGNOSTIC_TEST

PCR and NGS-WGS on stools and respiratory samples

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) in Infectious diseases department and Intensive care unit, whatever the severity of the clinical form. n=30 Sampling dates: COVID-19 diagnostics day (d0), day-2, day-4, day-end of hospitalization, day-post hospitalization

You may qualify if:

• Age: men or women of 18 years-old or more
• Clinical signs: hospitalised patient for SARS-CoV-2 infection, nasopharyngeal PCR-confirmed (or any other sample) (in: Infectious diseases department, Intensive care unit), whatever the severity of the clinical form.
• The subject gave his/her informed and writen consent, after complete explanations on the research schedule.
• Compulsory affiliation to a social security scheme.
• Previous medical examination, when a patient is admitted to the hospital, according to good clinical practices.

You may not qualify if:

• Subject corresponding to articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public health code:
• pregnant woman, parturient or breastfeeding woman
• Minor person
• Person of full age under guardianship, curatorship, safeguard of justice
• Woman who wants to be pregnant during the study period
• Person in psychiatric care - articles L. 3212-1 and L. 3213-1 who do not fall under the article L. 1121-8 (without consent hospitalisation)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Schvoerer

Vandœuvre-lès-Nancy, 54511, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stools, respiratory samples, blood samples The samples will be studied for viral genome.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Evelyne ES Schvoerer, Prof.

  University hospital Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

El Mehdi MS Siaghy

CONTACT

+33383155276; m.siaghi@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. E Schvoerer

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: October 5, 2022
• Study Start: November 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2025
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)